EpilepsyEPASNCT03900468
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
A study testing Activa™ PC and Percept™ PC Neurostimulation Systems in people with Epilepsy, run by MedtronicNeuro at 8 sites in 2 countries.
Trial summary
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Activa™ PC and Percept™ PC Neurostimulation Systems
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Mar 2020to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one ictal event
- Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase
- Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness
- Age 18 or older at the time of enrollment
- Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff
- Able to use the Patient Programmer with or without the assistance of a caregiver
- Ability of the subject or legal representative to understand and provide signed consent for participating in the study
- Willing and available to attend visits as scheduled and to comply with the study protocol
Who cannot join
- Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification)
- Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary
- Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit
- Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to the Enrollment Visit
- Surgical candidate for and willing to undergo resective surgery
- Evidence of a neurological condition that is likely to progress (e.g., brain tumor, arteriovenous malformations or cavernous angiomas)
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- Diagnosed with a progressive or degenerative neurological disorder affecting the brain
- Significant medical condition that may impact study participation in the opinion of the investigator
- Presence of any of the following within 1 year prior to the Enrollment Visit: psychiatric illness hospitalization, suicide attempt or symptoms of psychosis (hallucinations, delusions) unrelated to an ictal state, a post-ictal state or a medication
- Malignancy or history of malignancy within 1 year prior to the Enrollment Visit (excluding resected basal cell carcinomas)
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator, RNS) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). In the case of an implanted vagus nerve stimulator (VNS), CMM study assessment collection may occur with the device implanted but may not begin until the VNS has been off for at least 30 days. The VNS generator must be explanted prior to or at the time of the DBS neurostimulator implant and the leads removed or trimmed and capped. In the case of a subject who had been previously implanted with a responsive neurostimulator (RNS) but had a full system explant, a subject cannot begin CMM study assessment collection until the RNS has been off for at least 30 days.
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. This includes administration of any antiplatelet or anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use, chronic aspirin use of greater than 325 mg/day, and any participant with a history of hemorrhagic stroke
- History of drug or alcohol abuse within the past year
- Condition or disease that is known to require repeat magnetic resonance imaging (MRIs)
- Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
- Implant Criteria
- Experienced an average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days (all seizure types)
- Completed a qualifying baseline diary. A qualifying baseline diary meets at least one the following criteria: 1) a study diary with at least 28 completed days; 2) a pre-existing diary with at least 70 completed days.
- Completed 3-month CMM visit
- No suicide attempt or other self-harm behaviors within past year (assessed by Columbia Suicide Severity Rating Scale (C-SSRS) at 3-month CMM Visit)
- For female subjects of child-bearing potential, has negative pregnancy test and if sexually active continues using reliable form of birth control.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Emory University Hospital
Atlanta, Georgia, 30303-3049
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
University of Kansas Medical Center
Kansas City, Kansas, 66160-8500
University of California Los Angeles (UCLA)
Los Angeles, California, 90095-1406
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905
University of California San Francisco UCSF Medical Center
San Francisco, California, 94143
Czechia1 site
Fakultni nemocnice u sv. Anny v Brně/ Milan Brazdil
Brno, 656 91
About this study
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up.
- Conditions
- Epilepsy
- Being tested
- Activa™ PC and Percept™ PC Neurostimulation Systems
- Keywords
- Epilepsy, Deep Brain Stimulation, DBS, EPAS
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activa™ PC and Percept™ PC Neurostimulation SystemsDevice
Implanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Devices, Clinician Tablet, Clinician Programmer Therapy Application Software, Clinician Programmer Communicator, Patient Programmer
| Study group | Role | What they receive |
|---|---|---|
| Active Deep Brain Stimulation (DBS) | Experimental | Not described Receives: Device: Activa™ PC and Percept™ PC Neurostimulation Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction in Total Seizure Frequency
The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness
Measured: Pre-implant compared to 36 months post-implant
Secondary outcomes (4)
Percentage Reduction in Total Seizure Frequency
The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness
Measured: Pre-implant compared to 12 months post-implant
Percentage Reduction in Total Disabling Seizure Frequency
The percentage of total disabling seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness
Measured: Pre-implant compared to 12 months post-implant
Percentage Reduction in Temporal Lobe Originated Seizure Frequency
The percentage of temporal lobe originated seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness
Measured: Pre-implant compared to 12 months post-implant
SUDEP Rate Characterization
To characterize the Sudden Unexplained Death in Epilepsy (SUDEP) rate. Any participant deaths will be reported in the study database and SUDEP will be evaluated and reported by the site. The Clinical Events Committee (CEC) will evaluate all deaths and make the final determination of SUDEP used for this objective.
Measured: Implant to 36 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start5 Mar 2020
- Primary completion15 Oct 2025
- Study completion26 Feb 2026
Why it stopped: Study was terminated early since effectiveness and safety of the DBS Therapy System for Epilepsy was evaluated by using real-world evidence (RWE) gathered from the Medtronic Registry for Epilepsy (MORE).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900468
- Sponsor's protocol ID
- 1677
- Acronym
- EPAS
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
- ClinicalTrials.gov ID
- NCT03900468
- Acronym / sponsor ID
- EPAS / 1677
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Deep Brain Stimulation, DBS, EPAS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early since effectiveness and safety of the DBS Therapy System for Epilepsy was evaluated by using real-world evidence (RWE) gathered from the Medtronic Registry for Epilepsy (MORE).
- Enrolment
- 29 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Deep Brain Stimulation (DBS) | Experimental | Device: Activa™ PC and Percept™ PC Neurostimulation Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one ictal event
- Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase
- Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness
- Age 18 or older at the time of enrollment
- Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff
Key exclusion criteria (21 listed)
- Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification)
- Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary
- Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit
- Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to the Enrollment Visit
- Surgical candidate for and willing to undergo resective surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activa™ PC and Percept™ PC Neurostimulation SystemsImplanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Devices, Clinician Tablet, Clinician Programmer Therapy Application Software, Clinician Programmer Communicator, Patient Programmer | Device | Active Deep Brain Stimulation (DBS) |
Primary outcome
Percentage Reduction in Total Seizure Frequency
Time frame: Pre-implant compared to 36 months post-implant
The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness
4 secondary outcomes
Percentage Reduction in Total Seizure Frequency
Time frame: Pre-implant compared to 12 months post-implant
Percentage Reduction in Total Disabling Seizure Frequency
Time frame: Pre-implant compared to 12 months post-implant
Percentage Reduction in Temporal Lobe Originated Seizure Frequency
Time frame: Pre-implant compared to 12 months post-implant
SUDEP Rate Characterization
Time frame: Implant to 36 months post-implant
Results and safety
The study was stopped early (reason given: Study was terminated early since effectiveness and safety of the DBS Therapy System for Epilepsy was evaluated by using real-world evidence (RWE) gathered from the Medtronic Registry for Epilepsy (MORE).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activa™ PC and Percept™ PC Neurostimulation Systems in people with Epilepsy, run by MedtronicNeuro at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated early since effectiveness and safety of the DBS Therapy System for Epilepsy was evaluated by using real-world evidence (RWE) gathered from the Medtronic Registry for Epilepsy (MORE).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Total Seizure Frequency (time frame: Pre-implant compared to 36 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.